{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"7"}]}],"title":"Any TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"6"}]}],"title":"Any tipifarnib-related TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"1"}]}],"title":"Any serious TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"1"}]}],"title":"Any tipifarnib-related serious TEAE"}],"denoms":[{"counts":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"7"}],"units":"Participants"}],"description":"An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with it. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AE severity was rated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03.: grade 1(mild), grade 2(moderate), grade 3(severe), grade 4(life-threatening), grade 5(death). An AE was considered serious if resulted in any of the following: death, life-threatening, caused inpatient hospitalization or prolonged it, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital abnormality/birth defect, or was an important medical event.","groups":[{"description":"Participants with CMML were grouped by KRAS/NRAS mutational status (wild type \\[WT\\], mutation \\[Mut\\], missing) and given tipifarnib 1200mg twice daily (BID) for 7 days in alternating weeks (Days 1-7, 15-21) in 28-day cycles.","id":"OG000","title":"CMML"},{"description":"Participants with MDS/MPN were stratified by ratio of expression (high or low) between CXCR4 and CXCR2 (CXCR4/2 ratio) receptors to receive tipifarnib at a dose of 400 mg, orally, BID on Day 1 through 21 of each 28-day treatment cycle.","id":"OG001","title":"MDS/MPN"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"FAS: All enrolled participants who received at least one dose of tipifarnib. Data was pooled into CMML and MDS/MPN arms as pre-specified in statistical analysis plan (SAP).","reportingStatus":"POSTED","timeFrame":"Up to approximately 3 years","title":"Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)","type":"SECONDARY","unitOfMeasure":"Participants"}